Brazil eliminates a premarket approval pathway, instead allowing for premarket notification. Previously, Brazil has had a “Cadastro” pathway to register Class II medical devices and IVDs. This pathway required more extensive documentation (like a technical dossier) for Class II and higher-risk Class I devices. However, on September 18, 2020, the Brazilian regulatory agency, National Health...Read More

The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device...Read More

The Australian medical device regulatory division TGA has release a new online tool to assist manufacturers with classifying their products.  The SME Assist tool “is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.”Read More

View the english version of the China FDA (CFDA) website.  Formerly the State FDA (SFDA), the CFDA is promoting use of 62304 for medical device software and essentially ISO/IEC 14764 for IT maintenance.  It is also actively expanding its requirements related to cybersecurity of networked devices.Read More

In August 2014, the Australian Therapeutic Goods Authority (TGA) gave a presentation on its approach to software regulation of medical devices.  This is a short and very clear high level presentation that explains the TGA’s focus and use of relevant standards such as 62304 as well as its focus on safety and risk management. View...Read More

The International Medical Device Regulators Forum (IMDRF) SaMD draft of a quality system for Software as a Medical Device is available for public comment.Read More

The International Medical Device Regulators Forum (IMDRF) in which FDA participates continues to publish many documents including several related to software.Read More

The IMDRF issued “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.” This guidance provides terminology and possible framework for the industry and regulators to work from in discussing and dealing with risk related to standalone software used as a medical device.Read More

IECEE published Document OD-2044 Ed. 2.2, Evaluation of Risks Management in medical electrical equipment according to IEC 60601-1 and IEC/ISO 80601-1. The procedure intends to provide a uniform approach to the Certification Body Testing Laboratory and Manufacturer on assessment and documentation of compliance with the relevant clauses of IEC 60601 standard series related to the...Read More

The International Medical Device Regulators Forum (IMDRF) issued a final document “Software as a Medical Device(SaMD): Key Definitions” on December 9, 2013. IMDRF SaMD defRead More

The Therapeutic Goods Administration of the Australian Department of Health released a document on 13-Sep-2013 entitled “Regulation of medical software and mobile medical ‘apps’.”  This explains at a high level Australia’s approach to regulation of medical software.  It indicates a risk based approach is taken and that all medical devices are expected to meet the...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The SFDA prepared a draft document entitled "Explanations on the Basic Requirements of Application for Registration of Medical Device Software" on April 28, 2012, which is linked below. This was initially translated to English by JIRA (Japan Industries Association...Read More

This link provides a ten-year strategy document for information technology use in healthcare in England. NHS Power of InformationRead More

The Joint Initiative on SDO Global Health Informatics Standardization is formed to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counterproductive standardization efforts.Read More

Attached is a .pdf of a draft guidance from the Chinese medical device regulatory agency (SFDA) that was sent out for comment. SoftwareCPR reviewed and provided a number of comments. It is one of a number of actions by the SFDA indicating movement to more active regulation of medical devices and the software they contain....Read More

This link contains an August 2007 draft Korean KFDA guideline entitled “Medical Software Evaluation Guidelines.” This guidance focuses on examining information about the software and what it does, rather than how it may fail or risk management for those failures. There is significant emphasis and specificity in revision numbering and change control. Korea KFDA Software GuidelineRead More